Fwd: [SSRI-Research] Ethics of Non-Consensual Human Experimentation-NPR

[Guest guest]

JustSayNo

Tue, 6 Apr 2004 14:29:30 -0400

[sSRI-Research] Ethics of Non-Consensual Human Experimentation-NPR

 

Mary Faith Marshall (mmarshall); Mark McClellan MD

(COMMISSIONER); Bernard A. Schwetz (BSCHWETZ); Tommy Thompson

(hhsmail)

 

ALLIANCE FOR HUMAN RESEARCH PROTECTION (AHRP) Promoting openness and full

disclosure http://www.ahrp.org

 

FYI

 

Below is a transcript of an NPR discussion about the ethics of a non-consensual

artificial blood experiment. The discussion was slanted toward proceeding with

highest risk non-consensual experimentation on the basis of unproven claims.

 

The position taken by the company representative and by one of the researchers

conducting the trial was as expected. A former trauma nurse in the military

expressed impatience with the slow progress in trauma medicine. She wants the

tests to be done on soldiers in Iraq.

 

I think the position taken by bioethicist, Mary Faith Marshall, Ph.D., is

particularly disturbing inasmuch as it sheds light on the ethics of mainstream

bioethicists. In June, 2000 Dr. Marshall was appointed by (then) Secretary of

Health and Human Services, Donna Shalala, chair of the National Bioethics

Advisory Committee until it was disbanded by President Bush in July 2002.

 

NPR transcript--Ms. MARY FAITH MARSHALL says work on a blood substitute shows

that sometimes there is a need to make exceptions, even to first rules about

research.

 

" This is not Sunday school ethics of the sort where there's good or bad or right

or wrong, and that's clear cut. To not try and advance our knowledge in a slow,

thoughtful, careful way would be perhaps a bigger moral crime, if you will, or

moral problem. "

 

The Nuremberg Code (1947) is the most authoritative ethical / legal code of

medical ethics. All subsequent codes of ethics, including the Code of Federal

Regulations, are guided by the Nuremberg Code whose first principle

 

mandates: " the voluntary consent of the human subject is absolutely essential. "

 

When influential, mainstream American bioethicists defend experimenting on

non-consenting human beings by dismissing the foremost international moral

principle of medical research, as " Sunday school ethics, " we have a major moral

crisis in medical research.

 

The Alliance for Human Research Protection (AHRP) and medical experts whom we

have consulted have grave concerns about the safety of this unproven product and

its use in trauma patients who cannot exercise their right to voluntary,

informed consent:

 

There is no question that natural human blood provides the safest best life

sustaining chance of survival for trauma patients. The artificial blood trial

proposes to use a product that has not been proven safe inasmuch as in earlier

trials (on whom?) used historical controls as comparators to determine the

product's safety--rather than using a control group of patients receiving real

blood. Therefore, any claim about its safety is invalid.

 

Among the risks of using artificial blood are its propensity to raise blood

pressure, and its tendency to scavenge nitric oxide instead of oxygen. This puts

patients at risk of vascular thrombosis. In previous artificial blood trials

there was significant evidence of toxicity, myocardial infarction and renal

failure. For critically ill trauma patients these effects are lethal. For the

sake of patients' safety, why not provide ambulances with saline and O negative

type blood which is safe and universally compatible with all patients?

 

Why not limit clinical trials to less ill patients who could consent and whose

lives would not be in mortal danger? If the artificial blood proves safe for

these patients and it doesn't raise blood pressure or cause myocardial

infarction or renal failure, then there may be justification in its use on

trauma patients.

 

The findings upon which Northfield Laboratories claims its product is safe and

effective are not valid because they used historical controls which do not

reflect current survival rates due to improved methods of treating trauma

patients. Furthermore, unless the company discloses all the safety data from all

its trials it is not possible to validate the company's claims about the safety

of its artificial blood product.

 

The Alliance for Human Research Protection (AHRP) rejects efforts to substitute

personal informed consent with " community consent " -surely a degradation of one's

humanity and an illegitimate infringement of one's right as an individual, to

informed consent.

 

* What does " community consent " mean and how does it protect the

 

rights of an individual human being?

 

* When others decide, the risks for human subjects are always higher.

 

* What other medical decisions affecting the life of an individual,

 

shall be made on the basis of " community consent? "

 

* Who will bear responsibility for making bad choices causing human

 

beings to die?

 

* How many non-consenting people will be sacrificed on the commercial

 

altar of new product development?

 

~~~~~~~~~

 

NPR Transcription Title: PROFILE: ETHICS INVOLVED IN USING BLOOD SUBSTITUTE ON

TRAUMA PATIENTS

 

Show 2004-03-11

 

Series: MORNING EDITION

 

 

Cat. Title: ETHICS OF USING EXPERIMENTAL BLOOD SUBSTITUTE

 

BOB EDWARDS, host:

 

One of the sacred rules of medicine is that doctors cannot do research on human

subjects without that person's agreement. So what happens when doctors seem

close to making a product that could save thousands of lives a year, but the

only way to know for sure is to test it on people who are in shock? That's the

clash of values that's going on in an effort to make a breakthrough in trauma

medicine. NPR's Joseph Shapiro reports.

 

JOSEPH SHAPIRO reporting:

 

As the chief nurse at a US Army field hospital in Kosovo, Jimmie Keenan saw the

victims of gunshots, land mines and other violence every day. One unforgettable

patient was a boy just six years old.

 

Lieutenant Colonel JIMMIE KEENAN: He was playing hide-and-seek with his friends,

and he was shot by a sniper in the back. The bullet went through his liver, and

the liver's a very vascular organ, and he was more probably dead than alive when

he got to our Combat Support Hospital.

 

SHAPIRO: The boy kept losing blood, so Keenan and others on the trauma unit

rolled up their sleeves and did something that had been done by military nurses

and doctors for more than a century. They donated their own blood.

 

Lt. Col. KEENAN: We'd done whole blood transfusions since the Civil War, and it

really bothered me to think that we were not able to advance in research. Here

it is 1999, and I'm still doing whole blood transfusions that they had done

since Civil War times.

 

SHAPIRO: The boy survived, and Keenan came back to the United States. She got a

job in the Washington office of a Texas senator. As part of her work, she asks,

`Why hadn't the Army developed some kind of blood substitute, something that

could be stored for long periods of time and even in extreme heat, something

that could be used where blood was hard to get, like a battlefield?' Keenan

found out that the Army did want to do such research, but there was a law that

said it couldn't.

 

Lt. Col. KEENAN: I was really surprised because, as a trauma nurse--that's my

background--I said, `This is hard to believe; that we cannot fund trauma

research or look for a blood substitute or test these kind of critical,

life-saving items that we need on the battlefield.'

 

SHAPIRO: The ban was on testing human subjects without their consent, and there

was good reason for it, like the Tuskegee Syphilis Experiment, in which

government doctors studied the effects of advanced syphilis on a group of

largely illiterate, black sharecroppers and let the men die without treatment.

When it was reported in 1972, Congress passed restrictions on such research. But

over time many scientists worried that the law had gone too far. One reason was

that it slowed down some important research, like on a blood substitute. It

would have to be tested in the field on the victims of car accidents, stabbings

and shootings, people in shock, who could not volunteer. Keenan pushed for

change, and two years ago Congress let military researchers do such studies with

tight safeguards. The government had already made the same kind of exceptions

for university and private researchers, like Dr. Steven Gould. He runs a company

called Northfield Laboratories, and it's spent decades

developing a blood substitute, or more accurately a red cell substitute, called

PolyHeme.

 

Dr. STEVEN GOULD (Northfield Laboratories): And the process begins by lysing or

cracking the cells. Actually, we destroy the cell to try and harvest the

hemoglobin protein which exist inside the cell. It's the active ingredient in

the red blood cell that carries the oxygen.

 

SHAPIRO: Gould's company got special government approval to test it, and since

the start of the year, ambulance crews in four cities have started giving it to

accident victims. Dr. Ernest Moore is chief of trauma surgery at Denver Health

Medical Center.

 

Dr. ERNEST MOORE (Chief of Trauma Surgery, Denver Health Medical Center): I have

been involved in clinical trials virtually full-time for 26 years at our

institution and have never seen anything that has the promise of this.

 

SHAPIRO: Before the trials started in Denver, Moore and other doctors at the

hospital held weeks of public meetings.

 

Dr. MOORE: We then went out into the community and met with every neighborhood

health gathering we could find. It consisted of meetings of half a dozen

individuals in some communities to several hundred in others.

 

SHAPIRO: That's part of a compromise created by the government. If a researcher

wants to experiment on people who can't give their permission, then the

researcher must first convince the public that the test is worth doing and get

something called community consent. In the blood substitute trial there's a way

for any individual to opt out of the experiment, although perhaps not a very

practical one. In Denver, people can choose to wear a blue, plastic bracelet

that says they don't want to be in the experiment in case one day they get into

some severe accident. Not everyone agrees that even these well-intentioned steps

do enough to protect someone in shock.

 

Ms. VERA SHARAV (Alliance for Human Research Protection): Well, at that point

they're totally out of it. Simply, things are done to them. You know, they're

not volunteers, and they're not consenting. They're non-consenting human

subjects.

 

SHAPIRO: Vera Sharav runs a patient lobby called the Alliance for Human Research

Protection, and she says scientists should never compromise a basic human right,

like using people for testing without their agreement.

 

Ms. SHARAV: This is experimental. That's the problem. And experimental means it

involves risks. In this case, we're talking usually life and death.

 

SHAPIRO: She points out that an earlier experiment with another company's blood

substitute went horribly wrong. Test patients died of organ failure, and the

study was stopped abruptly. Officials at Northfield Laboratories say their

product works differently. It's already been tested on 171 trauma patients in

hospitals without the problems of the earlier blood substitute, and it increased

survival rates, too. Mary Faith Marshall is a bioethicist at the University of

Kansas. She says work on a blood substitute shows that sometimes there is a need

to make exceptions, even to first rules about research.

 

Ms. MARY FAITH MARSHALL (University of Kansas): This is not Sunday school ethics

of the sort where there's good or bad or right or wrong, and that's clear cut.

To not try and advance our knowledge in a slow, thoughtful, careful way would be

perhaps a bigger moral crime, if you will, or moral problem.

 

SHAPIRO: Right now four hospitals in Denver, Chicago, Memphis and Wilmington are

testing the red cell substitute on trauma victims. About 20 hospitals are

expected to join by the end of the year. But there's one place where the

experiment is not being conducted, someplace where it might help the most, in

Iraq. Lieutenant Colonel Jimmie Keenan is now the commander of the Army's field

medical training site in San Antonio, and she's heard that medics in Iraq still

roll up their sleeves to give blood. Keenan says that without a blood

substitute, the military has been forced to try other things, like finding

better ways to store blood in battlefield surgical units.

 

Lt. Col. KEENAN: We have portable refrigerators that plug into our Humvees.

There's a new product that was developed that almost looks like one of those

thermal lunch boxes, but it's much better than that that can store blood at

extreme temperatures.

 

SHAPIRO: But Keenan says those are hardly an answer. They can store only a small

amount of blood, even less than one wounded soldier might need in the crucial

first hour after being wounded. The company that makes the blood substitute says

the Department of Defense does want to test it in Iraq and that it's trying to

work out the details of expanding the study to the battlefield. Joseph Shapiro,

NPR News.

 

EDWARDS: The time is 29 minutes past the hour.

 

Copyright C2004 National Public RadioR. All rights reserved. No quotes from the

materials contained herein may be used in any media without attribution to

National Public Radio.

 

FAIR USE NOTICE: This may contain copyrighted (C ) material the use of which has

not always been specifically authorized by the copyright owner. Such material is

made available for educational purposes, to advance understanding of human

rights, democracy, scientific, moral, ethical, and social justice issues, etc.

It is believed that this constitutes a 'fair use' of any such copyrighted

material as provided for in Title 17 U.S.C. section 107 of the US Copyright Law.

This material is distributed without profit.